FIG. 1 illustrates a supply chain 100. A set of manufacturers, 102_1 and 1022_2, distribute products to a set of warehouses 104_1 and 104_2, respectively. Warehouse 104_1 then distributes products to first and second distributors 106_1 and 106_2, while warehouse 104_2 distributes products to third and fourth distributors 106_3 and 106_4. The first distributor 106_1 then distributes products to one or more retail outlets, such as a first retailer 108_1. The remaining distributors distribute products to retails 108_2, 108_3, and 108_4.
Arrows 110 illustrate the insertion of counterfeit goods into the supply chain 100. In one case, counterfeit goods are introduced at a warehouse 104_2 and in another case counterfeit goods are introduced at a distributor 106_4. In either case, enterprises downstream from the counterfeit insertion event have a difficult time identifying the counterfeit goods.
Arrow 112 illustrates a possible path for an improper resale or return of an item. In this case, the distributor 106_2 is bypassed and therefore the resale and return rules potentially enforced by the distributor 106_2 are bypassed.
Arrows 114 illustrate potential improper import paths into the supply chain 100. In this case, distributor 106_1 and retailer 108_1 directly receive improperly imported goods. Thus, import restrictions to be enforced by warehouses 104 are bypassed.
The foregoing supply chain abuses and many other supply chain abuses are coming under increasing scrutiny. In addition, there is growing interest in tracking product movement to optimize legitimate supply chain operations. For example, improved information on the movement of a product through a supply chain allows enterprises to more closely analyze trends in product consumption. This allows enterprises to implement the supply chain more efficiently. In addition, more comprehensive supply chain information allows more accurate predictions of future consumption patterns.
The potential to thwart supply chain abuses and to improve supply chain efficiency has led various government agencies and large commercial enterprises to require the use of radio frequency (RG) tags. A radio frequency tag is analogous to a bar code in the sense that it is used to uniquely identify a product. However, where a bar code relies upon a visual pattern to uniquely identify a product, an RF tag uses an RF signal signature to uniquely identify a product. An RF tag reader or scanner adjacent to an RF tag records the presence of the RF tag. The reader or scanner can then deliver RF tag information to a database, allowing the RF tag information to be processed.
While the use of RF tags within a single enterprise (e.g., a manufacturer, a warehouse, a distributor, or a retailer) is known, there are many challenges associated with the use of RF tags across enterprises (e.g., tracking RF tag information from a manufacturer through a retailer). One problem with cross-enterprise analysis is efficient processing of the vast amount of information associated with the movement of multiple products through multiple tiers of multiple supply chains.
Supply chain abuses are coming under increasing scrutiny, especially in industries where the abuse can lead to the loss of human lives. Recently, the number of investigations by the U.S. Food and Drug Administration (FDA) into counterfeit pharmaceuticals has increased to over 20 per year, after averaging only 5 per year through the late 1990's. Counterfeit drugs pose significant public health and safety hazards. Counterfeit products may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or contaminated materials. As a result, patients may be put at risk for serious adverse health consequences. For example, Procrit™, a drug used by cancer and AIDS patients, was recently counterfeited and the drug was replaced with non-sterile tap water, which could have caused sever bloodstream infections.
The FDA is aggressively pursuing anti-counterfeit measures, including: unit of use packaging, tamper evident packaging, authentication technologies, listing of high potential counterfeit drugs, and RFID tracking.
The Food, Drug and Cosmetic ACT (FDCA) requires the FDA to regulate drug manufacturers and to approve drugs for sale. This federal law also requires state governments to regulate the drug distribution system by licensing and regulating drug wholesalers. A number of states are working on bills to regulate the pharmaceutical supply chain. For example, a California bill (SB 1307) is expected to solve the following problems: (1) Counterfeit products introduced by repacking of drugs by licensed wholesalers and pharmacists. (2) Drugs that have been diverted and travel circuitous routes through facilities with minimal or non-existent records before reaching their final destination, which makes them untraceable. (3) Improper actions by “closed” pharmacies, which fill prescriptions for specific patient populations (commonly skilled nursing care facilities), but do not fill prescriptions for the general population. These organizations periodically sell the below market price drugs that they acquire to secondary wholesales, who in turn sell the drugs in the general market. There have been cases where legitimate wholesalers have unknowingly purchased counterfeit drugs in the secondary market and resold them to pharmacies. (4) The absence of a “pedigree” is a principal challenge in ensuring the integrity of the drug distribution system. A pedigree is a history of all the transactions related to an individual product (e.g., container of drugs). Currently, there is no effective means to verify the source and the history of any given bottle of drugs sitting on a pharmacy shelf. (5) Distribution channels for prescription drugs is not straightforward, sometimes involving circuitous paths from manufacturers, wholesalers, re-packagers, institutional pharmacies, closed door pharmacies, and foreign markets.
SB 1307 is sponsored by the California Board of Pharmacy to substantially decrease the threat of counterfeit drugs and drug diversion. Much of this proposal draws from recently adopted laws in Nevada and Florida and from recent draft revisions to model laws published by the National Association of Boards of Pharmacy. The proposal is designed to address challenges presented by the existing distribution system for prescription drugs. Techniques will be required to comply with new regulatory safeguards, such as those pending before various legislatures.
In view of the foregoing, it would be highly desirable to provide a technique for authenticating products, such as pharmaceutical drugs.